Improving Adherence in Adolescents and Young Adultswith Bipolar Disorder

提高双相情感障碍青少年和年轻人的依从性

• 批准号: 10172981
• 负责人: Melissa P Delbello
• 金额: $ 24.72万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-08 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10172981
• 关键词: Academic Medical Centers; Address; Adherence; Adolescence; Adolescent; Adolescent Development; Adolescent and Young Adult; Adult; Age; Alcohol consumption; Behavior; Behavior Therapy; Bipolar Disorder; Caregivers; Characteristics; Clinical; Clinical Treatment; Communication; Conflict (Psychology); Custom; Data; Development; Evidence based intervention; Family; Feedback; Focus Groups; Foundations; Funding; Goals; Health; Health Personnel; Homelessness; Hospitalization; Imprisonment; Individual; Intervention; Knowledge; Measures; Mediating; Methodology; Monitor; Neurobiology; Occupational; Outcome; Patients; Pharmaceutical Preparations; Pharmacotherapy; Phase; Process; Provider; Questionnaires; Randomized Controlled Trials; Recovery; Relapse; Research Personnel; Risk Behaviors; Risk Factors; Risk-Taking; Self Management; Standardization; Statistical Data Interpretation; Subgroup; Supervision; Symptoms; Tablets; Testing; Time; United States National Institutes of Health; Universities; Vulnerable Populations; base; cognitive interview; critical developmental period; effectiveness trial; efficacy trial; emerging adult; empowered; experience; feasibility testing; follow-up; health related quality of life; high risk; high risk population; high-risk adolescents; improved; innovation; medication compliance; modifiable risk; mortality; patient oriented; prevent; preventive intervention; primary outcome; psychiatric symptom; psychoeducational; response; secondary outcome; service intervention; skills; social; substance use; suicidal risk; therapy design; treatment as usual; trial design

PROJECT SUMMARY The most common onset of bipolar disorder (BD) is during late adolescence and early adulthood. While pharmacotherapy is effective for BD symptoms in adolescents and young adults (AYA), poor adherence occurs in more than 65% of AYAs and is associated with low rates of recovery, high rates of relapse and a 5.2 fold increase in suicide risk. Poor adherence is a critical yet modifiable risk factor of poor outcomes in AYAs with BD. AYAs are an ideal BD subgroup to target and test adherence interventions given the potential impact of enhanced adherence on social, educational and occupational goals during this critical developmental period which can lay the foundation for lifelong BD self-management skills. To date, there are no interventions that specifically target adherence in AYAs with BD. This R34 proposal, written in response to RFA-MH-18-706, Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions will modify and test in AYAs with BD, an effective customized adherence enhancement (CAE) intervention developed for adults with BD by the investigative team. CAE is a brief, practical adherence promotion intervention that is highly generalizable to real-word clinical settings. In adults, CAE improves adherence significantly more than a rigorous BD-specific educational control. The investigative team is based in two academic medical centers (Case Western Reserve University/CWRU and University of Cincinnati/UC) led by two NIH-funded PIs with complementary strengths. The proposed 3-phase project will identify relevant characteristics of AYAs and needed refinements to CAE (Phase 1) and standardize the intervention using iterative refinements based on patient feedback (Phase 2). Phases 1 and 2 will be completed over a 12-month time-period. In Phase 3 (months 13-36) we will test the feasibility, acceptability and preliminary efficacy of the adapted approach using a randomized controlled trial (RCT) design in a high-risk, high-need group: AYAs ages 16-21 with BD who are poorly adherent with prescribed BD medications. The overall hypothesis is that CAE for poorly adherent AYAs with BD (CAE-AYA) will be associated with improved adherence at 6-month follow-up compared to enhanced treatment as usual (ETAU). The primary outcome will be change from baseline in the Tablets Routine Questionnaire (TRQ) and electronic adherence monitoring (SimpleMed boxes). Secondary outcomes will evaluate change in psychiatric symptoms and health- related quality of life. Additional analysis will examine the posited mechanisms of adherence change in BD AYAs as it relates to the adherence barriers of inadequate bipolar knowledge, poor communication with clinicians and family, unstable medication routines and substance use/risky behaviors. If proven effective, the proposed trial will pave the way for a rigorous efficacy trial of CAE-AYA.

项目总结